Tip protector sleeve

ABSTRACT

Assemblies and methods of inserting a delivery catheter assembly into a working channel are disclosed. In accordance with some embodiments, a delivery catheter assembly is disclosed in which a tip protector sleeve is locked onto an elongated catheter sheath and slideable over a length of the elongated catheter sheath between a proximal-stop position and a distal-stop position along the elongated catheter sheath.

BACKGROUND

Embodiments of the present invention relate to the field minimallyinvasive surgical medical devices and medical procedures. Morespecifically, embodiments of the present invention relate to devices andmethods used for transcervical gynecological procedures.

Female contraception and sterilization may be affected by transervicallyintroducing an object into a fallopian tube to inhibit conception.Devices, systems and methods for such a contraceptive approach have beendescribed in various patents and patent applications assigned to thepresent assignee. For example, U.S. Pat. No. 6,526,979, U.S. Pat. No.6,634,361, U.S. patent application Ser. No. 11/165,733 published as U.S.Publication No. 2006/0293560 and U.S. patent application Ser. No.12/605,304 describe transcervically inserting an insert (also referredto as implant and device) into an ostium of a fallopian tube andmechanically anchoring the insert within the fallopian tube. One exampleof such an assembly is known as “Essure” ® from Conceptus, Inc. ofMountain View, Calif. Tissue in-growth into the “Essure” ® insertprovides long-term contraception and/or permanent sterilization withoutthe need for surgical procedures.

The insert may be delivered to the fallopian tube with a deliverycatheter assembly such as the one illustrated in FIG. 1. The deliverycatheter assembly 100 is formed of a control device 102 such as ahandle, an elongated sheath 104, and an insert 106. The deliverycatheter assembly 100 may be transcervically positioned into the uterusand the fallopian tubes via a hysteroscope system.

Referring to FIG. 2 the hysteroscope system 200 may include a workingchannel 202 into which the delivery catheter assembly is inserted.Advancement of the delivery catheter system within the uterus and thefallopian tubes is usually facilitated by distending the uterus with adistention fluid, such as saline, and viewing the placement with thehysteroscope system. A valve clamp 208, such as a ball valve clamp, andan access port 206 are positioned at the tip of the working channel 202.Closing the valve clamp 208 may seal the entrance of the working channel202 to prevent a distention fluid from leaking out of the access port206. A sealing cap 230 including a pierceable end 232 can be placed overthe access port 206 to prevent distention fluid from leaking out of thehysteroscope system when a delivery catheter assembly occupies theworking channel of the hysteroscope system.

An introducer 220 may be used in order to prevent damaging the tip theelongated sheath 104 or insert 106 of the delivery catheter assembly 100during insertion through the pierceable end 232 of the sealing cap 230and access port 206, and into the working channel 202 of thehysteroscope system 200. Introducer 220 includes a sheath portion 222and slit opening 224 to aid in grasping and in the removal of theintroducer 220. The introducer 220 is inserted through the pierceableend 232 of the sealing cap 230 and into the working channel 202 prior toinserting the delivery catheter assembly 100. When the introducer 220 isinserted through the sealing cap 230, fluid can spray out of theintroducer 220 and onto the physician or physician's assistant. Theamount of fluid spray-back can be significant depending on thedistention fluid pressure during the procedure.

Referring to FIG. 3, after placing the introducer 220 into the workingchannel 202, the tip of delivery catheter assembly 100 is inserted intothe slit opening 224 and through the sheath 222 of the introducer 220 inorder to advance the delivery catheter assembly 100 into the workingchannel 202 of the hysteroscope system. This is typically performed assoon as possible after placement of the introducer 220 into the workingchannel 202 in order to minimize the amount of fluid spray-back from theintroducer. The introducer 220 may then be removed or may be kept inplace throughout the procedure. After insertion of the delivery catheterassembly 100 into the introducer 200, an amount of distention fluid maystill leak from between the introducer and elongated sheath 104 of thedelivery catheter assembly 100.

SUMMARY

Embodiments of the present invention generally provide assemblies andmethods of inserting a delivery catheter into a working channel of anendoscope, such as a hysteroscope system for accessing a femalereproductive system. While embodiments of the invention are describedwith reference to a hysteroscope system, it is understood that theembodiments are not limited to such and may also be compatible withother optical surgical devices. In one aspect, embodiments of theinvention describe a tip protector sleeve which functions as anintroducer and protects the tip of a delivery catheter assembly whenpiercing a sealing cap, as well as during insertion through an accessport, into the working channel and past a valve clamp of a hysteroscopesystem. In another aspect, embodiments of the invention describe amethod and system which may reduce the amount of fluid spray-back andleakage associated with inserting a delivery catheter assembly into theworking channel of a hysteroscope system.

One embodiment of the present invention relates to a delivery catheterassembly which may be used to deliver an insert to an ovarian pathway(e.g. a fallopian tube) of a female body. The delivery catheter assemblymay include a control device, an elongated catheter sheath having adistal end and a proximal end connected to the control device, and a tipprotector sleeve. The tip protector sleeve may be locked onto theelongated catheter sheath and slideable over a length of the elongatedcatheter sheath between a proximal-stop position and a distal-stopposition along the elongated catheter sheath. The delivery catheterassembly may further include an interference stop which determines thedistal-stop position and prevents the tip protector sleeve from slidingoff of the distal end of the elongated catheter sheath. For example, theinterference stop may include a male interference part which interfereswith sliding of a female interference part over the elongated cathetersheath. The male interference part may be fixed to the elongatedcatheter sheath, and the tip protector sleeve may comprise the femaleinterference part. The tip protector sleeve may additionally incorporatea sealing valve to reduce the amount of fluid spray-back and leakageassociated with inserting the delivery catheter assembly into theworking channel of a hysteroscope system

Another embodiment of the present invention relates to a method offorming a delivery catheter assembly which includes sliding a tipprotector sleeve over a distal end of an elongated catheter sheath andtoward a control device, and then fixing a bump onto a distal region ofthe elongated catheter sheath. Alternatively, the bump may be fixed ontothe distal region of the elongated catheter sheath, and then the tipprotector sleeve is slid over a proximal end of the elongated cathetersheath toward the bump prior to attaching the control device to theelongated catheter sheath. The control device may prevent the tipprotector sleeve from sliding off a proximal end of the elongated sheathand define, in part, a proximal-stop position. The bump may prevent thetip protector sleeve from sliding off of a distal end of the elongatedcatheter sheath and define, in part, a distal-stop position. In anembodiment, the bump may be fixed onto a distal region of the elongatedcatheter sheath by crimping a band onto the elongated catheter sheath.It is not necessary to crimp the entire length of the band, and only aproximal end of the band is crimped onto the elongated catheter shaft inan embodiment.

Another embodiment of the present invention relates to a method ofdelivering an insert into a body lumen such as an ovarian pathway (e.g.a fallopian tube) of a female body. Utilizing a delivery catheterassembly in accordance with embodiments of the invention the tipprotector sleeve is positioned at the distal-stop position, and the tipprotector sleeve is inserted through a pierceable end of a sealing cap,through an access port of a hysteroscope system and into a workingchannel of the hysteroscope system. In accordance with embodiments ofthe invention, the distal end of the elongated catheter sheath andinsert are inserted through the pierceable end of the sealing cap,through the access port and into the working channel of the hysteroscopesystem simultaneously with the tip protector sleeve in the distal-stopposition. The distal end of the elongated catheter sheath and insert maythen be advanced through the tip protector sleeve and beyond thehysteroscope system to a target location within the body lumen where theinsert is deployed within the body lumen. In an embodiment, the tipprotector sleeve is advanced through the sealing cap into the workingchannel until a flanged mechanical stop, such as a bead or flaredportion, abuts the sealing cap (or access port if a sealing cap is notutilized) prior to advancing the elongated sheath and insert to thetarget location.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side view illustration of a deliverycatheter assembly.

FIG. 2 is an isometric view illustration of a hysteroscope system and anintroducer.

FIG. 3 is an isometric view illustration of a delivery catheter assemblyinserted into an introducer and working channel of a hysteroscopesystem.

FIG. 4 is a side view illustration of a tip protector sleeve inaccordance with an embodiment of the invention.

FIG. 5A is a side view illustration of a delivery catheter assembly witha tip protector sleeve at a proximal-stop position in accordance with anembodiment of the invention.

FIG. 5B is a side view illustration of a delivery catheter assembly witha flanged mechanical stop of a tip protector sleeve in a cavity of acontrol device in accordance with an embodiment of the invention.

FIG. 5C is a side view illustration of a delivery catheter assembly witha tip protector sleeve fastened into the proximal-stop position by afriction fitting in accordance with an embodiment of the invention.

FIG. 5D is a side view illustration of a delivery catheter assembly witha tip protector sleeve screwed into the proximal-stop position inaccordance with an embodiment of the invention.

FIG. 6 is a side view illustration of a delivery catheter assembly witha tip protector sleeve at a distal-stop position in accordance with anembodiment of the invention.

FIG. 7 is a close-up side view illustration of the proximal end of a tipprotector sleeve over an elongated catheter sheath in accordance with anembodiment of the invention

FIG. 8 is a close-up cross-sectional side view illustration of theproximal end of a tip protector sleeve over an elongated catheter sheathin accordance with an embodiment of the invention

FIG. 9 is a cross-sectional side view illustration of a tip protectorsleeve in accordance with an embodiment of the invention.

FIG. 10 is a cross-sectional side view illustration of a tip protectorsleeve in accordance with an embodiment of the invention.

FIGS. 11A-11C are cross-sectional side view illustrations of tipprotector sleeves incorporating various sealing valves in accordancewith embodiments of the invention.

FIGS. 12A-12C are isometric view illustrations of inserting a deliverycatheter assembly into a working channel of a hysteroscope system inaccordance with an embodiment of the invention.

DETAILED DESCRIPTION

Embodiments of the present invention generally provide assemblies andmethods of inserting a delivery catheter into a working channel of anendoscope, such as a hysteroscope system or other optical surgicaldevice for accessing a female reproductive system. Various embodimentsand aspects will be described with reference to details discussed belowand the accompanying drawings will illustrate the various embodiments.The following description and drawings are illustrative of the inventionand are not to be construed as limiting the invention. Numerous specificdetails are described to provide a thorough understanding of variousembodiments of the present invention. However, in certain instances,well-known or conventional details are not described in order to providea concise discussion of embodiments of the present invention.

In an embodiment, a delivery catheter assembly includes a controldevice, an elongated catheter sheath having a distal end and a proximalend connected to the control device, and a tip protector sleeve.Referring to the FIG. 4 the tip protector sleeve 300 may include anelongated shaft 302, a flanged mechanical stop 304 at a proximal end,and a distal end 306. The distal end 306 can be flat or angled to assistwith piercing of a sealing cap. In an embodiment, the distal end 306 hasan approximately 45 degree angled tip. Elongated shaft 302 may be formedof a material and to a thickness which can be molded and does not bucklewhen piercing a sealing cap. For example, elongated shaft 302 may beformed of a material such as polyether ether ketone (PEEK).

Flanged mechanical stop 304 may provide variety of functions, be formedof a variety of materials and have a variety of shapes and sizes as willbe explained in further detail with regard to FIGS. 5A-12C. For example,flanged mechanical stop 304 may be formed of a moldable material such aspolycarbonate, or from the same material as the elongated shaft 302.Flanged mechanical stop 304 may be sized and shaped larger than theinside diameter (ID) of a corresponding access port opening to a workingchannel or pierceable end of a sealing cap if present in order to act asa stop mechanism that controls the insertion depth of the tip protectorsleeve 300 into the working channel. Flanged mechanical stop 304 mayalso be sized and shaped to be gripped by an operator's hand to assistwith sliding of the tip protector sleeve 300 over a length of theelongated catheter sheath 404 of a catheter assembly. In this respect,one function may be as a handle at the proximal end of the tip protectorsleeve 300. Flanged mechanical stop 304 may also incorporate a sealingvalve to reduce the amount of fluid spray-back and leakage associatedwith inserting the delivery catheter assembly into a working channel.

Referring to FIGS. 5A-6, a delivery catheter assembly 400 in accordancewith embodiments of the invention is illustrated in which the tipprotector sleeve 300 is locked onto and slideable over a length of theelongated catheter sheath 404. The delivery catheter assembly 400 may beformed by sliding a tip protector sleeve 300 over a distal end of anelongated catheter sheath 404 and toward a control device 402, and thenfixing a bump 408 onto a distal region of the elongated catheter sheath402. Alternatively, the bump 408 may be fixed onto the distal region ofthe elongated catheter sheath 402, and then the tip protector sleeve 300is slid over a proximal end of the elongated catheter sheath 402 towardthe bump 408 prior to attaching the control device 402 to the elongatedcatheter sheath 402. The control device 402 may prevent the tipprotector sleeve 300 from sliding off a proximal end of the elongatedsheath 402 and define, in part, a proximal-stop position. The bump 408may prevent the tip protector sleeve 300 from sliding off of a distalend of the elongated catheter sheath 402 and define, in part, adistal-stop position. An operator may grip the flanged mechanical stop304 by hand, for example between a thumb and index finger, and slide thetip protector sleeve over the elongated catheter sheath 404 between theproximal-stop and distal-stop positions.

FIG. 5A is an illustration of the tip protector sleeve 300 positioned ata proximal-stop position. In the embodiment illustrated in FIG. 5A, theflanged mechanical stop 304 abuts a distal end of the control device402, though other proximal-stop positions along the elongated cathetersheath 404 are contemplated in accordance with embodiments of theinvention. For example, FIGS. 5B-5D are illustrations of embodiments inwhich the control device 402 is configured to allow flanged mechanicalstop 304 to slide within a cavity 420 located at a distal portion of thecontrol device 402. Such embodiments may be useful during operation inorder to utilize the full working length of the elongated cathetersheath 404. In this manner, the distal end of the control device 402 canbe advanced to abut the access port 206 of the hysteroscope system orthe pierceable end 232 of a sealing cap 230 if desired during operation.Alternatively, the distal end of the control device 402 can be advancedover the access port 206 of the hysteroscope system or over sealing cap230 and the flanged mechanical stop 304 is allowed to abut the accessport 206 or the pierceable end 232 of the sealing cap 230. Asillustrated in FIG. 5B, flanged mechanical stop 304 may be slid intocavity 420 to abut a back wall 422 of the cavity at the proximal-stopposition. Flanged mechanical stop 304 may be also configured to fastenonto the handle 402 at the proximal-stop position. For example, FIG. 5Cis an illustration of an embodiment in which flanged mechanical stop 304may be slid into cavity 420 and fastened into the proximal-stop positionby a friction fitting with sloped walls 424 of the cavity. FIG. 5D is anillustration of an embodiment in which flanged mechanical stop 304 maybe screwed into cavity 420 in which threads 330 on flanged mechanicalstop 304 mate with threads 430 inside cavity 420 to fasten tipprotection sleeve 300 in the proximal-stop position. In an embodiment, asuitable fastening mechanism for fastening tip protector sleeve 300 ontocontrol device 402 is able to hold the tip protector sleeve 300 in theproximal-stop position during withdrawal of the delivery catheterassembly 400 from the working channel of the hysteroscope system.

Referring now to FIG. 6 an operator may slide the tip protector sleeveover the elongated catheter sheath 404 between the proximal-stopposition and the distal-stop position illustrated in FIG. 6. Asillustrated, the distal end 306 of tip protector sleeve 300 may extenddistally beyond a distal end of the elongated catheter sheath 404 andinsert 406 when at the distal-stop position. In this manner, the tipprotector sleeve 300 may protect the distal ends of the elongatedcatheter sheath 404 and insert 406 during piercing of a sealing cap andduring insertion into the working channel and past a valve clamp of thehysteroscope system.

An interference stop may determine the distal-stop position and preventthe tip protector sleeve 300 from sliding off of the distal end of theelongated catheter sheath 404. In an embodiment, the interference stopincludes a male interference part which interferes with sliding of afemale interference part over the elongated catheter sheath. Referringagain to FIG. 5A, the male interference part may comprise a bump 408fixed to the elongated catheter sheath 404. Bump 408 may be formed alongonly a portion of the circumference of the elongated sheath, or mayencircle the circumference of the elongated sheath. In an embodiment,bump 408 is a band fixed to and encircling the circumference of theelongated catheter sheath. In an embodiment, bump 408 is fixed to theelongated catheter sheath 404 with a sufficient shear strength to ensurethat the tip protector sleeve may be removed from a working channel of ahysteroscope system along with removal of the elongated catheter sheath404.

FIG. 7 is a close-up side view illustration of the proximal end of a tipprotector sleeve over an elongated catheter sheath in accordance with anembodiment of the invention. FIG. 8 is a close-up cross-sectional sideview illustration of the proximal end of a tip protector sleeve over anelongated catheter sheath in accordance with an embodiment of theinvention. As illustrated in FIGS. 7-8, flanged mechanical stop may be abead 304A having a barrel-like shape, though embodiments of theinvention are not limited to such a shape. In an embodiment, bead 304Ais fixed to shaft 302 with an adhesive.

Referring to FIG. 8, in an embodiment bead 304A may be fixed to aproximal end of the elongated shaft 302. Bead 304A may include a distalportion 308 surrounding the proximal end of the elongated shaft 302, ashoulder portion 310 extending proximally of the elongated shaft 302,and a backstop 312. The distal portion 308 may be fixed to the elongatedshaft 302 with an adhesive. In an embodiment, the backstop 312 abuts theproximal end of the elongated shaft 302. Backstop 312 may also have aheight which is greater than a thickness of the elongated shaft 302. Forexample, the height may be defined as the distance between and insidediameter (ID) of the backstop and an ID of the distal portion 308 of thebead 304A. In accordance with various embodiments of the invention, thedimensions and location of the backstop 312 as they relate to thedimensions and location of bump 410 create an interference stop whichdetermines the distal-stop position and prevents the tip protectorsleeve from sliding off of the distal end of the elongated cathetersheath 404.

In an embodiment, the tip protector sleeve 300 is locked onto an“Essure” ® delivery catheter assembly. In such an embodiment, the ID ofelongated catheter sheath 404 may be between 0.0405 and 0.0420 inchesand the outside diameter (OD) of elongated catheter sheath 404 may bebetween 0.0538 and 0.0560 inches. Elongated catheter sheath 404 may beformed of a polyether block amide also known under the trade name PEBAX.The OD of elongated catheter sheath 404 may be used to determine the IDof bump 408. In an embodiment, bump 408 may have an ID between 0.0545and 0.0555 inches and an OD between 0.0575 and 0.0580 inches. In oneembodiment, the ID of bump 408 may be smaller than the OD of theelongated catheter sheath 404. In another embodiment, the OD of theelongated catheter sheath 404 is smaller than the ID of bump 408. Forexample, the OD of the elongated catheter sheath 404 may be between0.0538 and 0.0542 inches.

Bump 408 may be a band that is fixed to and encircles the elongatedcatheter sheath. Bump may be fixed to the elongated catheter sheath 404by a variety of mechanisms including adhesive and crimping. In anembodiment, bump 408 is formed of a material which is strong enough toresist deformation during operation of the delivery catheter assembly,yet malleable enough to be suitable for crimping. For example, stainlesssteel possesses suitable strength and malleability. In an embodiment,only a distal end 410 of the band is crimped onto the elongated cathetersheath, as illustrated in FIG. 8. This leaves the proximal end, with theoriginal OD between 0.0575 and 0.0580 inches to act as the maleinterference part which interferes with the ID of backstop 312functioning as a part of the female interference part. While anembodiment of bump 408 is described in detail in FIG. 8 in operablerelationship with bead 304A, it is understood that bump 408 can be inoperable relationship with other flanged mechanical stops, such as thoseillustrated in FIGS. 9-11C.

Still referring to FIG. 8, bead 304A may be formed of a variety ofmaterials and have a variety of shapes and sizes to perform a variety offunctions. In one aspect, bead 304A may be sized and shaped larger thanthe inside diameter (ID) of a corresponding access port opening to aworking channel or pierceable end of a sealing cap if present in orderto act as a stop mechanism that controls the insertion depth of the tipprotector sleeve 300 into the working channel. In one aspect, bead 304Amay perform the function as a handle for gripping by the operator. Inanother aspect, bead 304A may include a backstop 312 which functions aspart of the female interference part. In an embodiment, bead 304A has anOD of approximately 0.112 inches. The distal portion 308 of bead 304Amay have an ID of approximately 0.070 and may be bonded to the OD ofelongated shaft 302. Backstop 312 may have an ID which is smaller thanan OD of the proximal end of bump 408. For example, backstop 312 mayhave an ID between 0.0565 and 0.0575 inches. In such an embodiment,backstop 312 has a height that extends from the ID of back stop 312 tothe ID of the distal portion 308 of the bead 304, or approximately 0.013inches.

In accordance with embodiments of the invention tip protector sleeve 300may be locked onto the delivery catheter assembly 400. Shaft 302 may beused to pierce a sealing cap and protect the tip of the insert 406,elongated catheter sheath 404 or guidewire during insertion into theworking channel and past a valve clamp of a hysteroscope system. In anembodiment, the shaft 302 and elongated catheter sheath 404 may beadvanced into a working channel of a hysteroscope system withoutallowing a significant amount of fluid (e.g. saline) spray-back orleakage from the delivery catheter assembly. The elongated cathetersheath 404 may additionally be slid through the shaft 302 to deliver theinsert 406 to a body lumen, while the delivery catheter assembly 400does not allow a significant amount of fluid leakage. Referring now toFIG. 12A, the shaft 302 may pierce the pierceable end 232 of a sealingcap 230 with the tip of the shaft 306. The outside diameter of the shaft302 may fit tightly in the pierceable end 232 effectively creating awater tight seal between the sealing cap 230 and tip protector sleeve300.

The reduction of fluid spray-back and leakage may also be achieved bycontrolling the shape and dimensions of the tip protector sleeve 300 asit interacts with the elongated catheter sheath 404 and bump 408. In anembodiment, shaft 302 may be approximately 2.82 inches long from theproximal end to the distal end of the tip 306, which may be angled.Shaft 302 may have an ID between 0.0585 and 0.0605 inches and an ODbetween 0.0690 and 0.0710 inches. The shaft 302 ID may be selected tonot allow for fluid to flow proximally between the shaft 302 andelongated catheter sheath 404 (and bump 408), while still allowing forthe elongated catheter sheath 404 to slide and be advanced through theshaft 302. In such and embodiment, a minimum clearance between the ID ofthe elongated shaft 302 (e.g. 0.059 inches) and the OD of the elongatedcatheter sheath 404 (e.g. 0.055 inches) provides sufficient resistanceto spray-back and leakage. Such a minimum clearance may be effective foroverlapping constant diameters of the elongated shaft 302 and elongatedcatheter sheath 404.

Referring now to FIG. 9, an embodiment for tip protector sleeve 300B isillustrated. As illustrated in FIG. 9, tip protector sleeve 300Bincludes an elongated shaft 302, a bead 304B and inner shaft 320. Tipprotector sleeve 300B operates similarly as tip protector sleeve 300with one difference being that backstop 322 is the distal end of innershaft 320. In such an embodiment, the shape and dimensions of tipprotector sleeve 300B are controlled so that bump 408 interferes withmovement of the distal end, backstop 322 of inner shaft 320. In such anembodiment, bead 304B may be sized and shaped to act as a stop mechanismthat controls the insertion depth of the tip protector sleeve 300B intothe working channel and may perform the function as a handle forgripping by the operator

Referring now to FIG. 10, another embodiment for tip protector sleeve300C is illustrated. As illustrated in FIG. 10, tip protector sleeve300C includes an elongated shaft 302, a neck portion 332, and a flaredportion 304C. Tip protector sleeve 300C operates similarly as tipprotector sleeves 300 and 300B. One difference is that the neck portion332 operates as the backstop for bump 408. The neck portion 332 may beintegrally formed with the elongated shaft 302 or be a separate memberbonded to the inside diameter of elongated shaft 302 Likewise flaredportion 304C may be integrally formed with the elongated shaft 302 or bea separate member bonded to the outside diameter of elongated shaft 302.In such an embodiment, flared portion 304C may be sized and shaped toact as a flanged mechanical stop that controls the insertion depth ofthe tip protector sleeve 300C into the working channel and may performthe function as a handle for gripping by the operator.

Embodiments of the invention are also envisioned in which the elongatedcatheter sheath 404 does not have a constant OD along its length. Inaccordance with some embodiments, the tip protector sleeve 300 mayinclude a change in ID or a valve to accommodate variations in the OD ofthe elongated catheter sheath 404, or to more effectively seal anelongated catheter sheath 404 with a constant OD. Referring again toFIG. 9, inner shaft 320 is illustrated as having a smaller ID than theID of elongated shaft 302. In addition to functioning as an interferencepart, the ID of inner shaft 320 may more effectively accommodate areduction in OD of the elongated catheter sheath 404. Referring again toFIG. 10, the ID of neck portion 332 may also more effectivelyaccommodate a reduction in OD of the elongated catheter sheath 404 inaddition to functioning as an interference part. Thus, a minimumclearance between the ID of inner shaft 320 or ID of neck portion 332and the OD of the elongated catheter shaft 404 may provide enhancedresistance to fluid-spray back.

FIGS. 11A-11C are illustrations embodiments of a tip protector sleeveincorporating various sealing valves to reduce the amount of fluidspray-back and leakage between the tip protector sleeve and elongatedsheath of the delivery catheter assembly. While illustrated separately,it is understood that the embodiments illustrated in FIGS. 11A-11C maybe combined with other embodiments of the invention. More specifically,any of the sealing valves described in reference to the illustrations inFIGS. 11A-11C may be combined with any of the embodiments furtherdescribing the proximal-stop and distal-stop positions.

FIG. 11A is an illustration of a tip protector sleeve 300D including anelongated shaft 302, a housing 304D, and valve 340. Housing 304D mayfunction as a stop mechanism that controls the insertion depth of thetip protector sleeve 300D into the working channel and may perform thefunction as a handle for gripping by the operator. The elongated shaft302 may be coupled to a distal tip 342 of the housing 304D which mayfunction as a backstop for interference with a bump 408 fixed to theelongated catheter sheath 404 at the distal-stop position. Housing 304Dadditionally houses valve 340 which is capable of accommodating multiplevariations in OD of the elongated catheter sheath 404. For example,valve 340 may be a silicone valve containing a slit at the distal endthat allows for a catheter shaft to pass through it. The siliconematerial may allow for the slit to conform to different shapes ordiameters while providing a seal. Due to the geometry on the distal endof the silicone valve, as fluid tries to pass from distal to proximal,the end of the valve may be pushed closed due to a chamfer on the end ofthe valve.

FIG. 11B is an illustration of a tip protector sleeve 300E including anelongated shaft 302, a housing 304E, and a compression valve 350including an screw cap 354 which may be threaded down onto an O-ring 352to compress it against the elongated catheter sheath 404. Housing 304Emay function as a stop mechanism that controls the insertion depth ofthe tip protector sleeve 300E into the working channel and may performthe function as a handle for gripping by the operator. The elongatedshaft 302 may be coupled to a distal tip 342 of the housing 304E whichmay function as a backstop for interference with a bump fixed to theelongated catheter sheath at the distal-stop position.

FIG. 11C is an illustration of a tip protector sleeve 300F including anelongated shaft 302, a housing 304F, and a compression valve 360including a cap 362, a compression spring 364 and a thin walled tube(not illustrated) inside the housing. For example, the thin walled tubemay be made of a material such as silicone. Threads between the cap 362and the housing 304F apply a twist motion to the tube. When the tube istwisted, an inner diameter of the tube tightens like an iris. Thecompression spring 364 keeps the cap 362 extended and the threads holdthe twist or keep the iris closed. When the cap 362 is pushed towardsthe housing 304F (spring compressed) the cap 362 untwists and the irisopens. In this manner the opening of the iris can be adjusted based uponthe OD of the elongated catheter sheath 404. Similar to tip protectorsleeves 300D and 300E, housing 304F may function as a stop mechanismthat controls the insertion depth of the tip protector sleeve 300F intothe working channel and may perform the function as a handle forgripping by the operator. The elongated shaft 302 may be coupled to adistal tip 342 of the housing 304F which may function as a backstop forinterference with a bump fixed to the elongated catheter sheath at thedistal-stop position.

A delivery catheter assembly in accordance with embodiments of theinvention may be utilized to deliver an insert to an ovarian pathway(e.g. a fallopian tube) of a female body. The delivery catheter assemblymay protect the tip of an elongated catheter sheath, guidewire, orinsert during piercing of a sealing cap and insertion into the workingchannel and past a valve clamp of a hysteroscope system and reduce theamount of fluid spray-back and leakage associated with inserting adelivery catheter assembly into the working channel of a hysteroscopesystem. In an embodiment, the delivery catheter assembly includes acontrol device, an elongated catheter sheath having a distal end and aproximal end connected to the control device, and a tip protector sleevelocked onto the elongated catheter sheath and slideable over a length ofthe elongated catheter sheath between a proximal-stop position and adistal-stop position along the elongated catheter sheath. The deliverycatheter assembly may further include an insert releasably disposedwithin the elongated catheter sheath. In an embodiment, the insertextends distally beyond the elongated catheter sheath. In an embodiment,the insert includes a preformed bend, as illustrated in FIG. 5, whichmay be utilized to assist with navigation through a curved portion of afallopian tube. Upon providing the delivery catheter assembly theoperator may grasp a flanged mechanical stop 304 or other suitableportion of the tip protector sleeve 300 to position the tip protectorsleeve at the distal-stop position illustrated in FIG. 6. If a sealingvalve is present on the tip protection sleeve 300, the sealing valve maythen be tightened onto the elongated catheter sheath 404 if necessary toprovide an optimal seal to protect against fluid spray-back and leakage.

Referring now to FIGS. 12A-12C, the operator may then pierce apierceable end 232 of a sealing cap 230 with the tip protector sleeve300 and insert the tip protector sleeve 300 through an access port 206of a hysteroscope system 200 and into the working channel 202 of thehysteroscope system. During insertion the tip protector sleeve 300 maybe advanced past a valve clamp 208 of the hystero scope system. The tipprotector sleeve protects against the possibility of the exposed portionof the insert 406 from catching on the valve clamp 208 and compromisingthe insert integrity. In accordance with embodiments of the invention,the distal end 410 of the elongated catheter sheath 404 and insert 406are inserted through the sealing cap 230 and access port 206, and intothe working channel 202 of the hysteroscope system simultaneously withthe tip protector sleeve 300 in the distal-stop position. Thesimultaneous insertion of the tip protector sleeve 300 and elongatedcatheter sheath 404 may avoid a problem of fluid spray-back associatedwith sequentially inserting an introducer followed by an elongatedcatheter sheath. In an embodiment, the tip protector sleeve 300 may beadvanced into the working channel simultaneously with the elongatedcatheter sheath and insert 406 until the flanged mechanical stop 304abuts against the access port 206 or sealing cap 230, if present, asillustrated in FIG. 12B.

The distal end 410 of the elongated catheter sheath 404 may then beadvanced past the hysteroscope system 200 as illustrated in FIG. 12C,and onto a target location with the body lumen. The insert 406 may thenbe deployed into the body lumen. Depending upon operator preference, thetip protector sleeve 300 may remain inserted in the working channel 202during the elongated catheter sheath 404 advancement and insert 406deployment procedures or removed from the working channel 202. Inaccordance with many embodiments of the invention it is understood thatthe tip protector sleeve 300 is permanently locked onto the elongatedcatheter sheath. It is also contemplated that the tip protector sleeve300 could be removed from the catheter assembly after initiallyadvancing the catheter assembly into the working channel, for example,by including a tear joint in the tip protector sleeve in which the tipprotector sleeve can be manually torn off of the elongated cathetersheath by the operator.

In an embodiment, the insert 406 and distal end 410 of the elongatedcatheter sheath 404 are advanced to the target location within the bodylumen while the flanged mechanical stop 304 on the tip protector sleeve300 abuts the access port 206 or sealing cap 320, if present. The amountof elongated catheter sheath 404 spanning between the flanged mechanicalstop 304 and control device 402 may depend upon the procedure andpatient's anatomy. It is envisioned that circumstances arise where theoperator may wish to insert the entire available working length of theelongated catheter sheath 404 into the patient and advance the controldevice 402 all the way to the access port or sealing cap, if present. Inaccordance with embodiments of the invention illustrated in FIGS. 5B-5D,this can be possible by including a cavity 420 in the control device 402to accommodate the flanged mechanical stop 304.

Once the insert 406 is deployed into the body lumen the deliverycatheter assembly may be withdrawn from the working channel of thehysteroscope system. In one embodiment, during withdrawal of thedelivery catheter assembly 400 from the working channel, the bump 408 onthe elongated catheter sheath 404 may be withdrawn proximally againstthe backstop of the tip protector sleeve 300 and cause the tip protectorsleeve 300 to be withdrawn from the working channel 202 of thehysteroscope system 200. In another embodiment, the flanged mechanicalstop 304 on the tip protector sleeve 300 can be fastened to the controldevice 402. In this manner, during withdrawal of the delivery catheterassembly 400 from the working channel, the tip protector sleeve 300remains fastened to the control device 402.

In the foregoing specification, various embodiments of the inventionhave been described. It will, however, be evident that variousmodifications and changes may be made thereto without departing from thebroader spirit and scope of the invention as set forth in the appendedclaims. The specification and drawings are, accordingly, to be regardedin an illustrative sense rather than a restrictive sense. Hence, thescope of the present invention is limited solely by the followingclaims.

What is claimed is:
 1. A method of forming a delivery catheter assemblycomprising: sliding a tip protector sleeve over a distal end of anelongated catheter sheath and toward a control device; fixing a bumponto a distal region of the elongated catheter sheath, wherein the bumpprevents the tip protector sleeve from sliding off of a distal end ofthe elongated catheter sheath.
 2. The method of claim 1, wherein fixinga bump onto a distal region of the elongated catheter sheath comprisescrimping.
 3. The method of claim 2, wherein crimping comprises crimpinga distal end of a band onto the elongated catheter sheath.
 4. The methodof claim 3, further comprising not crimping a proximal end of the bandonto the elongated catheter shaft.
 5. A method of delivering an insertcomprising: providing a delivery catheter assembly comprising: a controldevice; an elongated catheter sheath having a distal end and a proximalend connected to the control device; an insert releasably disposedwithin the elongated catheter sheath; and a tip protector sleeve lockedonto the elongated catheter sheath and slideable over a length of theelongated catheter sheath between a proximal-stop position and adistal-stop position along the elongated catheter sheath; positioningthe tip protector sleeve at the distal-stop position; inserting the tipprotector sleeve through an access port of a hysteroscope system andinto a working channel of the hysteroscope system; advancing the distalend of the elongated catheter sheath to a target location within a bodylumen; and deploying the insert inside the body lumen.
 6. The method ofclaim 5, wherein inserting the tip protector sleeve further comprisesadvancing a distal end of the tip protector sleeve past a valve clamp ofthe hysteroscope system.
 7. The method of claim 6, wherein inserting thetip protector sleeve comprises advancing the tip protector sleeve intothe working channel until a flanged mechanical stop on the tip protectorsleeve abuts the access port or a sealing cap coupled to the accessport.
 8. The method of claim 6, wherein the distal end of the elongatedcatheter sheath is advanced to the target location within the body lumenwhile the flanged mechanical stop on the tip protector sleeve abuts theaccess port or the sealing cap.
 9. The method of claim 5, furthercomprising removing the delivery catheter assembly from the workingchannel after deploying the insert inside the body lumen.
 10. The methodof claim 5, wherein removing the delivery catheter assembly from theworking channel comprises withdrawing a bump on the elongated cathetersheath proximally against a backstop of the tip protector sleeve tocause the tip protector sleeve to be withdrawn from the working channel.11. The method of claim 5, further comprising tightening a sealing valveof the tip protector sleeve onto the elongated catheter sheath afterpositioning the tip protector sleeve at the distal-stop position, andprior to inserting the tip protector sleeve through the access port ofthe hysteroscope system.